Diagnostic and Prognostic Accuracy of Gold Nanoparticles in Salivary Gland Tumours

Amina Fouad Farag60 enrolled

Overview

Nano-based diagnostic tool can provide promising highly sensitive, specific biomarker for early detection and treatment of salivary gland tumours compared to non-conjugated biomarkers and in turn improves patient prognosis and outcome.

Cancer stem cells form a small subset of highly tumorigenic cells within the bulk of the tumours which mainly responsible for initiation, invasion, rapid growth, metastasis and therapeutic resistance in different types of human cancers. Nowadays, nanotechnology has increasing attention in multi-disciplinary research fields. Conjugated gold nanoparticles are widely used as biomarkers and bio-delivery vehicles in the medicine as well as early and advanced cancer detection and treatment. The current work aimed to introduce a novel diagnostic and prognostic approach in early detection of cancer stem cells in salivary gland tumours using gold nanoparticles conjugated to CD24 (CD24-Gold Nanocomposite).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Carcinoma Ex Pleomorphic Adenoma of Salivary Glands Pleomorphic Adenoma of Salivary Glands

Interventions

CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reactionDIAGNOSTIC_TEST

new strategy where gold nanoparticles synthetized and added to CD24 primer forming CD24-Gold Nanocomposite to be used for detection of cancer stem cells

non-conjugated CD24 expression using Real-time quantitative polymerase chain reactionDIAGNOSTIC_TEST

conventional strategy using non-conjugated CD24 expression to used for detection of cancer stem cells

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Benign PA of major and minor salivary glands (PA group), * CXPA of major and minor salivary glands (CXPA group). * Border of excision biopsy of mucocele in the lip mucosa of healthy individuals used as normal controls (Control group). * Surgical excision of tumors with no preoperative chemotherapy or radiotherapy. For parotid tumours partial or total parotidectomy, Surgery was performed with or without facial nerve preservation and the later was carried out commonly when the nerve was involved by tumour. For tumours in the other glands, complete surgical excision with the involved gland and the suspicious adjacent structures was performed. Exclusion Criteria: * All epithelial origin salivary gland tumours other than PA and CXPA. * All mesenchymal origin salivary gland tumours. * All inflammatory and cystic lesions of salivary glands. * Metastasis in salivary glands. * Patients received preoperative chemotherapy or radiotherapy.

Locations (1)

Faculty of Dentistry, October 6 University

Giza, Egypt

Outcomes

Primary Outcomes

Diagnostic potential of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in determination of salivary gland tumours

we tested the differential expression of CD24-AuNC and non-conjugated CD24 biomarkers in all studied groups in order to identify the most sensitive and specific diagnostic biomarker to be used in detecting salivary gland tumours,

Time frame: Done immediately following completion of assessment for eligibility of enrolment in the present study (enrolment took about 6 months) and confirmation of definite diagnosis

Secondary Outcomes

Clinicopathological characteristics of the patients and their association with CD24-AuNC (Index test) and non-conjugated CD24 (Reference test) expressions

We investigated the relationship between both biomarkers' expression and clinicopathological characteristics of PA and CXPA patients such as age, gender, tumor site, tumor size (maximum diameter in mm), histopathological subtype, encapsulation, degree of invasion, facial nerve involvement and lymph node (LN) metastasis that may have direct relation with the tumor prognosis

Time frame: Done immediately following completion of assessment for eligibility of enrolment in the present study (enrolment took about 6 months) and confirmation of definite diagnosis

Prognostic significance of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in assessing disease progression and/or patient survival

we assessed the disease progression and/or patient survival and examined its association with biomarkers expression

Time frame: At regular intervals every 3 months for 24-months (follow-up period)

Data from ClinicalTrials.gov

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